Diagnostic Imaging Techniques for Shoulder Osteoarthritis

(UESOA Trial)

Not currently recruiting at 1 trial location

Overseen By Katie McIlquham

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Age >60, Shoulder trauma, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand shoulder osteoarthritis (OA), focusing on its causes and progression. Researchers use advanced imaging techniques like low-dose CT (a type of computed tomography scan with reduced radiation) and T1Rho MRI (a specialized magnetic resonance imaging technique) to study shoulder joints. The goal is to find ways to slow OA and reduce the need for shoulder surgeries. Participants should have a specific shoulder condition called posterior subluxation, where the upper arm bone shifts back more than usual, and either show early signs of OA or none at all. This trial may suit adults under 60 who haven't experienced significant shoulder injuries or conditions. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new insights and treatments for shoulder OA.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these diagnostic imaging techniques are safe for studying shoulder osteoarthritis?

Research has shown that the treatments in this study are safe. Studies have found that low-dose CT scans use much less radiation than standard CT scans, making them generally easy to handle with few side effects. They are designed to reduce radiation exposure while still providing clear images.

Motion analysis, another component of this study, is non-invasive. It tracks joint movement and muscle function during activities. This method poses no known safety issues, as it only observes and records motion.

Lastly, T1Rho MRI is a special imaging technique that provides detailed pictures of cartilage. It has been used safely in both healthy individuals and those with osteoarthritis. This method is non-invasive and does not involve radiation.

Overall, these treatments are considered safe with minimal risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these diagnostic imaging techniques for shoulder osteoarthritis because they offer new ways to detect and understand the condition early. The low-dose CT provides detailed images with less radiation exposure, making it safer compared to traditional CT scans. Motion analysis captures real-time movement, helping to assess how shoulder function is affected, while T1Rho MRI reveals subtle changes in cartilage health that aren't visible in standard MRIs. Together, these methods could lead to earlier and more precise diagnosis, potentially improving treatment outcomes for patients.

What evidence suggests that these diagnostic imaging techniques are effective for understanding shoulder osteoarthritis?

This trial will compare different diagnostic imaging techniques for shoulder osteoarthritis. Research has shown that low-dose CT scans effectively provide detailed images for diagnosing shoulder problems and planning surgeries, making them useful for understanding shoulder osteoarthritis (OA). Motion analysis, using advanced technology, promises to improve diagnostic accuracy and consistency in assessing shoulder issues. T1Rho MRI helps detect early cartilage wear and tear, which is important for tracking the progression of shoulder OA. While primarily diagnostic, these tools are crucial for developing future treatments by offering clear insights into how shoulder OA develops and progresses. ^{5 6 7 8 9}

Who Is on the Research Team?

Peter Lapner, MD

Principal Investigator

The Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for adults under 60 with shoulder osteoarthritis, specifically those showing more than 55% posterior humeral head subluxation on imaging. It's not suitable for individuals over 60, those with labral or rotator cuff issues, pre-existing joint deformities beyond grade I, neurological disorders of the upper limb, history of shoulder instability or trauma including fractures.

Inclusion Criteria

Posterior humeral head subluxation >55% (determined from imaging)

I am younger than 60 years old.

Exclusion Criteria

I am over 60 years old.

I have a joint deformity more severe than mild.

I have a rotator cuff injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments including T1Rho MRI, qCT, and functional/motion analysis

1-2 weeks

1 visit (in-person)

Ongoing Assessment

Participants undergo T1Rho MRI, qCT, and motion analysis at year 2 and year 4

5 years

2 visits (in-person) at year 2 and year 4

Finite Element Model Validation

Finite element model validation performed in years 2 and 3

2 years

Follow-up

Participants are monitored for safety and effectiveness after assessments

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Low-dose CT
• Motion Analysis
• T1Rho MRI

Trial Overview The study aims to understand the causes and progression of shoulder osteoarthritis by using low-dose CT scans, T1Rho MRI imaging techniques and motion analysis to observe changes in the joint over time.

How Is the Trial Designed?

Group I: Group 1: Early Degeneration ('Disease') Experimental Treatment 3 Interventions

Those who have posterior subluxation of the humeral head and show early signs of degeneration in their shoulder.

Group II: Group 2: No Degeneration ('Healthy') Active Control 3 Interventions

Those who have posterior subluxation of the humeral head and show no signs of degeneration.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

University of Ottawa

Collaborator

Trials

231

Recruited

267,000+

Citations

1. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0275297

The clinical performance of ultra-low-dose shoulder CT scans The ultra-low-dose protocol functioned well in the diagnosis of fracture pattern of an injured shoulder. The ultra-low-dose protocol scored more ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04634773

Unravelling the Etiology of Shoulder Osteoarthritis A low-dose, or quantitative (q) CT scan will be performed on the shoulder. This CT scan will be done to assess the bony structure of the shoulder, as well as ...

3. insightsimaging.springeropen.com insightsimaging.springeropen.com/articles/10.1186/s13244-025-02119-x

Diagnostic performance of dual-energy CT for ... This retrospective study evaluated patients diagnosed with rotator cuff disease who underwent third-generation dual-source DECT and 3.0-T MRI ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9512178/

The clinical performance of ultra-low-dose shoulder CT scans An ultra-low-dose protocol is adequate for the diagnosis of either displaced or non-displaced fractures of the shoulder joint even though minor flaws of images ...

5. withpower.com withpower.com/trial/phase-osteoarthritis-6-2021-2906e

Diagnostic Imaging Techniques for Shoulder Osteoarthritis ... Research shows that low-dose CT scans can effectively provide detailed images for diagnosing shoulder issues and planning surgeries, while MRI techniques like ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9992673/

Diagnostic accuracy of ultra-low-dose CT compared ... The ED for the ULD-CT protocol was significantly lower (shoulder, knee, ankle, wrist: 23.21 ± 2.24 μSv, 2.10 ± 0.25 μSv, 1.02 ± 0.11, 0.29 ± 0. ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11964493/

Low-dose Radiation Therapy (LDRT) in Managing ... Additionally, LDRT is generally well-tolerated and carries a lower risk of adverse effects compared to higher-dose radiation therapies used in ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1350453324001152

Geometric accuracy of low-dose CT scans for use in ... All low-dose protocols resulted in a >70 % reduction in the effective dose. Lower dose scans resulted in higher geometric errors; however, error magnitudes were ...

9. redjournal.org redjournal.org/article/S0360-3016(22)00357-1/fulltext

The Use of Low-Dose Radiation Therapy in Osteoarthritis LDRT has been shown to be a cost-effective, noninvasive treatment with minimal side effects. Further investigation into the potential role in ...